Method and apparatus for fractional skin treatment

ABSTRACT

An apparatus for cosmetic RF skin treatment where the RF energy supply is isolated from the patient treated, such that in course of treatment no undesired current flows through the subject body.

CROSS-REFERENCE TO RELATED REFERENCES

This application is related to the United States Application PublicationNo. 2006/0047281 and the U.S. patent application having the Ser. No. of12/324,932, both of these documents are incorporated herein byreference.

TECHNOLOGY FIELD

The method and apparatus generally relate to skin treatment proceduresand in particular to cosmetic skin resurfacing and rejuvenationprocedures.

BACKGROUND

Fractional skin resurfacing or rejuvenation is a recently developed skinablative technology. There are two types of devices used to ablate theskin: laser based devices and RF based devices. Both types of thesedevices ablate a pattern of extremely small diameter shallow holes orzones. The holes are microscopically small treatment zones surrounded byuntreated skin areas. The treatment results in a very rapid healing orrecovery and skin resurfacing of the treated. In the healing process ofthe treated zones, a layer of new skin appears, restoring a fresh,youthful complexion.

The pattern of small holes is typically produced by an X-Y scanninglaser beam or by application of RF energy or voltage. The laser isfocused on the skin and usually operates in pulse mode ablating micronsize holes in the skin.

RF based fractional skin treatment produces a scanning pattern of micronsize holes in the skin a similar to laser. Typically, the energy isdelivered to the skin by an applicator equipped by a tip having aplurality of voltage to skin applying/delivering elements or contactelements arranged in a matrix or in an array. The voltage to skinapplying elements are placed in contact with the segment of the skin tobe treated and driven by a source of suitable power and frequency RFenergy. Application of a high voltage RF pulse to the electrodes ablatesthe skin under the respective electrode forming a small hole.

In some instances application of laser or RF voltage pulses causesdiscomfort and even pain to the treated subject, although the experiencebased on the individual and as such, the pain sensation may be differentfrom subject to subject. In other instances there may be a difference inthe size of micro holes formed by the applicator at the same treatmentsession. Healing of larger size holes may take a longer period of timethan the healing process for smaller size holes and in some instances,the larger holes may tend to result in causing damage to the skin ratherthan producing the desired skin effect.

In order to soften the discomfort and lessen the pain and other sideeffects associated with the fractional treatment, practitioners havestarted using topically applied lidocaine cream or even oral sedation.

Fractional skin treatment is applicable in the correction of almost allcosmetic skin defects such as signs of aging, wrinkles, discolorations,acne scars, tatoo removal, and other skin defects. The cost of the RFbased products is lower than that of the products operating with laserradiation and they will most probably become widely used if thediscomfort and occasional pain associated with their use could beeliminated.

US Patent Application Publication No. 2006/0047281 and U.S. patentapplication Ser. No. 12/324,932 to the same assignee disclose RF basedproducts such as eMatrix™ suitable for fractional skin treatment.

GLOSSARY

In the context of the present disclosure “RF voltage” and “RF energy”are used interchangeably and have the same meaning. The mathematicalrelationship between these two parameters is well known and knowledge ofone of them allows easy determination of the other.

In the context of the present disclosure “skin resistance” and “skinimpedance” are used interchangeably and have the same meaning. Themathematical relation between these two parameters is well known andknowledge of one of them allows easy determination of the other.

The term “desired skin effect” as used in the present disclosure means aresult of RF energy application, which may be wrinkle removal, hairremoval, collagen shrinking or destruction, skin rejuvenation, and othercosmetic and skin treatments.

The term “plateau” of a function is a part of its domain where thefunction has constant value.

BRIEF SUMMARY

An apparatus for cosmetic RF skin treatment where the RF energy supplyis isolated from the subject treated, such that in course of treatmentno undesired current flows through the subject body. The apparatusincludes an applicator with a tip that is populated by a plurality ofvoltage applying dome shaped elements protruding from the tip surfaceand organized in one common cluster and a cluster of electrodes boundingthe dome shaped elements and having an area larger than the dome shapedelements have. The apparatus applies voltage to the elements with amagnitude sufficient to cause a desired skin effect. A current limiterlimits the RF induced current thereby preventing skin damage. Theapparatus continuously senses the treated skin segment impedance andvaries the RF energy at a low skin impedance and/or stops the pulse incases of too low or too high skin impedance.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A and 1B, collectively referred to as FIG. 1, are schematicillustrations of a prior art RF applicator tip for fractional skintreatment.

FIG. 2 is a schematic illustration of a prior art RF voltage supplyingcircuit for driving the RF applicator tip for fractional skin treatment.

FIGS. 3A through 3C are schematic illustrations of an equivalentelectric circuit of the tip for fractional skin treatment.

FIG. 4 is a schematic illustration of an exemplary embodiment of thepresent tip for fractional skin treatment driving circuit.

FIG. 5 is a schematic illustration of another exemplary embodiment ofthe present tip for fractional skin treatment driving circuit.

FIG. 6 is a schematic illustration of skin resistance variation underthe application of an RF energy pulse.

FIG. 7 is a schematic illustration of an exemplary embodiment of thepresent tip for fractional skin treatment control circuit.

FIG. 8 is a schematic illustration of an exemplary embodiment of thepresent RF applicator tip for fractional skin treatment.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The principles and execution of the method and the apparatus may bebetter understood with reference to the drawings and the accompanyingdescription of the non-limiting, exemplary embodiments, shown in theFigures.

Reference is made to FIG. 1, which is a schematic illustration of aprior art RF applicator tip for fractional skin treatment disclosed inthe U.S. patent application Ser. No. 12/324,932 to the same assignee. Acarrier 100 on which voltage to skin delivering elements or contactelements are formed may be a flexible or rigid article made of apolyimide film or similar material, with an exemplary thickness range of0.5 mil to 6 mil (12.5 micron to 150 micron). The term “carrier” in thecontext of the present disclosure means a substrate having an array ofvoltage to skin application elements, a two dimensional array or matrixof voltage to skin application elements. Substrate 104 has on one of itssurfaces 112 an array or matrix of miniature (microscopic), discrete,voltage to skin application elements 116 protruding from surface 112 andterminated by dome type shapes 120. A pattern of conductors 124 and 128shown in broken lines arranged on the back or second side of substrate104 enables addressing of all elements 116, a cluster of elements 116,or each of elements 116 individually. Carrier 100, having formed on it,the voltage to skin delivering elements is configured to allow quickattachment to an applicator and will be termed in the present documentas a “tip” or an “applicator tip.” An arrangement of RF contactsenabling connection to a source of radio frequency voltage is providedby forming on the back side of the carrier 104 contact points or strips108 communicating with respective contact arrangements made in substrate104. Voltage to skin delivering elements 116 are arranged in a symmetricpattern with all even rows 124 connected to one of the RF supply contactstrips or ports 124 and all uneven rows 128 connected to another orsecond contact strip or RF supply port 128.

FIG. 2 is a schematic illustration of a prior art RF voltage supplyingcircuit for driving the RF applicator tip for fractional skin treatment.A source of RF voltage 200 may be located in stand alone housing 204.Alternatively, the source of the RF voltage may be located in theapplicator case 208 shown in broken lines. The source provides RFvoltage to applicator tip 212, and in particular to voltage to skindelivering elements 216 through a shielded harness 220. Shield 224 isschematically shown in broken and doted lines. The length of the harness220 is selected to enable convenient caregiver operation and may be oneto two meters long, for example. There exists a certain parasiticcapacitance 232 and 236 between the shield 224 and each of the RFcurrent conducting lines 240 and 244. The treated subject has alsocertain capacitance 248. For skin treatment, tip 212 is placed incontact with a segment of the skin 228 to be treated. As a result ofuneven contact of the voltage to skin delivering elements 216 organizedinto even 124 and uneven 128 rows or clusters with segment of the skin228 to be treated, an undesired RF current path 252 may be formed. Thiscurrent passes through the subject 228 and may cause a painful sensationand even an electric shock to the subject.

FIG. 3 is a schematic illustration of an equivalent electric circuit ofthe tip for fractional skin treatment 212 being in contact with thetreated segment of the skin. FIG. 3A schematically shows the tip 212with all contact elements 330 located in uneven rows 1, 3, 5, and 7 ofthe tip 212 collectively marked as 302 and shown as connected to a firstRF port of RF voltage source 306 and all contact elements located ineven rows 2, 4, 6, and 8 collectively marked as 310 and shown asconnected to a second RF port of RF voltage source 306. All of thecontact elements are in contact with the upper skin layer 320 forexample, stratum corneum which has a relatively low conductivity, wherenumeral 324 marks dermis layer and even deeper skin layers that have arelatively high, as compared to stratum corneum, conductivity.

Referring to FIG. 3B, the electrical channel from each contact elementthrough the low conductance skin layer is represented as a resistor (forthe simplicity of the explanation channel capacitance is neglected). Thehigh conductivity dermis is represented as a common resistor Rs. Furtherequivalent electric scheme simplification is shown in FIG. 3C, where alluneven resistors have been replaced by an equivalent resistor Ru andeven rows resistors by Re. Typically, each of the individual contactelement resistors is 50K-100K Ohms, therefore Ru and Re are about 2KOhms each, whereas Rs is an order of magnitude smaller, about 200 Ohmsand it can be neglected for the purpose of the discussion.

Because not all of the voltage to skin delivering elements or contactelements 330 (FIG. 3A) may be properly attached to the skin and some ofthem may bear some dirt and other residuals from the previous treatment,and different skin segments may have different resistance, there is adifference in the resistance to current passing through each of thecontact elements and accordingly through the clusters (even or unevenclusters) they form. If the RF voltage or energy flows into any of theRu or Re resistors, it increases its resistance it generates a positivefeedback under which the larger resistor gets more energy than thesmaller one, its resistance increases more rapidly, therefore it getseven more energy, and so on. The end result is that the one of Ru or Reclusters, which had initially greater value finally takes most of theenergy and leaves a different imprint on the skin (for example, onlycontact elements located in even or uneven rows may leave an imprint).This reduces the efficacy of the treatment and generates undesired skineffects, excessive pain, and even electric shock.

In order to resolve this problem, as disclosed in the U.S. patentapplication Ser. No. 12/324,932 assigned to the same assignee, it ispossible to address individually each contact element or pin and connectit to the source of voltage through a large impedance, which can be aresistor, a small capacitor, a large inductor, or a combinations of allof them. This would stabilize the RF induced current to each individualchannel reducing the “competition” between the contact elements andclusters of contact elements. For sterilization and hygiene purposes useof disposable tips is preferred to the use of reusable tips. Addressingof each individual contact element however, complicates and increasesmanufacturing cost of such tips.

Another way to equalize the resistance or impedance of each contactelement and reduce the pain sensation and potential electric shocks tothe treated subject is to bring the skin by some initial treatment to anoptimal and more uniform resistance value, which for example may beabout 3000 Ohms. There will always be however, segments of skin wherethe resistance is low and any slight sweating may drive the skin tolower impedances.

FIG. 4 is a schematic illustration of an exemplary embodiment of thepresent tip driving circuit. The embodiment of FIG. 4 eliminates or atleast, greatly reduces the pain sensation and electric shock that couldaffect the treated subject. A low capacitance for example, 4 pF to 10 pFisolating transformer 404 is located in close proximity to the tip 212with the voltage to skin delivering elements 216. In the course ofoperation, transformer 404 reduces or completely eliminates currentsflowing through the subject body due to parasitic capacitances 408 and412 formed by the subject skin 320, 324 and the ground and between theshield 224 and each of the RF conducting lines 420 and 424. A controller432 governing operation of all of the apparatus devices may be locatedin housing 204. Controller 432 may have a processor, a memory, and otherdevices necessary for controlling the treatment process.

FIG. 5 is a schematic illustration of an additional exemplary embodimentof the present tip 212 driving circuit that eliminates, or greatlyreduces, pain sensation and electric shock that could affect the treatedsubject. In addition to the low capacitance transformer 404 one or morecapacitors 502 and 504 located in the current path and connected inseries to the electrodes 216 form a high pass filter. In the course ofapparatus operation, the high pass filter filters out the low frequencycurrents, to which the sensitivity of the treated subject is high,generated by plasma formed at the voltage to skin delivering elements216 being in contact with the skin 320, 324 and flowing through thesubject body in course of the apparatus/applicator operation. (referencecan be made to Guidelines for Limiting Exposure to Time-VaryingElectric, Magnetic, and Electromagnetic Fields up to 300 GHz;International Commission on Non-Ionizing Radiation Protection, Page 10.

Electrical resistance of skin differs from subject to subject andcomplicates proper RF energy value selection and application of the RFenergy for cosmetic skin treatment. Further to this, resistance of thesubject may vary under application of RF energy. FIG. 6 is a schematicillustration of skin resistance variation under the application of RFenergy in a pulse mode. Lines 602 and 606 mark different skin behaviorunder an RF energy pulse and lines 610 and 614 mark the upper and lowerskin resistance or impedance values that result in a desired skineffect, although because of the large variability of the treatedsubjects skin properties, there may be a need to set experimentallyother values matching a particular subject properties. The length of thepulse, as will be explained later, may vary from few milliseconds tohundreds of milliseconds or even seconds.

In order to establish proper treatment parameters prior to thetreatment, a system operator or user can calibrate the apparatus andoperational treatment parameters derived as a result of the calibrationare loaded into a look-up-table (LUT) that may be stored in the memoryof the controller 432. For the purpose of calibration, a known variableresistance modeling the subject and the tip behavior is connectedinstead of a subject to the RF voltage supply. In one of thecalibrations, a current flowing in the circuit at different RF voltagesand different resistance value is recorded and in another calibrationthe RF energy applied to the variable resistance, modeling differentskin impedance is recorded.

When skin is wet its resistance is low and with the application of theRF energy it continues to fall (line 606). Without being bound by aspecific theory it is believed that most of the RF energy applied to theskin is initially wasted to dry the skin and when the skin under theinfluence of RF energy becomes dry, the skin resistance begins growingto higher values. Resistance increase is believed to be connected withvaporization, accompanied or followed by tissue ablation. It isconsidered a good treatment (desired skin effect) when ablation iscreated in the tissue below the electrodes.

It has been experimentally established that treatment resulting in adesired skin effect takes place when the resistance of the subject'sskin is between Rlow and Rhigh, where the specific values depend on thenumber of electrodes in the tip and their arrangement and on the skinproperties. For a typical tip shown in FIG. 1, with 64 electrodes and adiameter of 250 μm each, Rlow is about 1500 Ohms and Rhigh is about 4000Ohms For the asymmetrical tip of FIG. 8, Rlow is about 600 Ohms andRhigh is about 1600 Ohms. When the skin resistance (or impedance) fallsbelow the lower limit, most of the RF energy applied to the skin iswasted on drying the skin and not on causing the desired skin effect.Generally, the upper skin resistance limit is in the vicinity of thestratum corneum resistance with the lower limit corresponding to wetskin. When the skin resistance is within the indicated resistancelimits, as shown by broken lines 610 and 614, application of RF to theskin through the voltage to skin delivering elements results in adesired skin effect. Continuous or pseudo continuous monitoring of theskin impedance during the RF pulse enables control of the energydelivered to skin. For example, when the resistance falls below thepre-set threshold of e.g. 600 Ohms, the time of the RF pulse may beincreased by the control, until the control unit identifies or detectsthe beginning of an increase in the resistance. From the time that thebeginning of the resistance increase is detected, the amount of energydelivered is either fixed or it takes into consideration the energydelivered up to that point, thereby allowing or ensuring the proper skineffect. It is also possible to cut off the RF pulses when the skinimpedance is below a pre-set impedance or resistance value and notifyoperator, to exclude inefficient pulses. Another possibility is tonotifying the operator on the low value of skin resistance and the needto dry out the skin. It is also possible to set the apparatus to delivera pre-set amount of energy to the skin.

It is possible to generalize the skin behavior under an RF pulse into atleast two typical cases, although a mixture of these cases and otherskin behavior may be present: a) skin resistance remains high throughall of the RF pulse application time and b) skin resistance drops downbelow the lower resistance limit and after it reaches (the functionreaches) a plateau it begins to rise. Accordingly, by monitoring thecurrent flowing in the voltage to skin delivering elements circuit, itis possible to set proper treatment parameters resulting in a desiredskin effect and not causing adverse side effects such as pain, burningsand other. It was found that resistances above Rhigh correspond to dirtytip and/or are caused by improper attachment of the tip to the skin. Inboth cases, the pulses may cause undesired pain. In order to reduce thepain, current limiter 704 (FIG. 7) or a control system immediately cutsthe pulse when the resistance is above a certain pre-set threshold. Thecontrol will notify the operator to check proper attachment of the tipto skin and/or clean the tip.

FIG. 7 is a schematic illustration of another exemplary embodiment ofthe present tip for fractional skin treatment driving circuit thateliminates pain sensation and electric shock that could affect thetreated subject. A sensing element 700 senses the current flowing in theimmediate to the tip for fractional skin treatment circuit. The sensingand sampling may be continuous or performed at very short timeintervals, for example every few tens of a microsecond. A fast responseRF induced current limiter 704 in course of operation sets a maximum tothe current which flows into the skin. Immediately, with the currentincrease above a pre-set value, it operates a fast switch 708 thatcloses the circuit directing the current to an energy absorbing element712, which dissipates the excessive energy as heat. The RF energyabsorbing element 712 may be packaged or even be a part of currentlimiter 704. The switch may be a bi-polar transistor, a MOSFET switch,an IGBT switch or any other fast switch. If the switch is operated inthe analogue regime, it can stabilize the current to the pre-set maximumvalue or below that value. The energy absorbing element 712 may be abank of resistors, bridge of diodes or similar devices. This protectsthe subject from electric shock, skin burn, and other potentialtreatment side effects.

FIG. 1 illustrates a prior art tip, which is basically a symmetrical tipincluding even and uneven arrays of electrodes. FIG. 8 is a schematicillustration of an exemplary embodiment of the present RF applicator tipfor fractional skin treatment that eliminates or significantly reducesthe “competition” between the tip electrodes. Although the tip 800 isfor a bi-polar treatment, it is an asymmetrical tip. Tip 800 has one ormore (a cluster) large “ground” electrodes 804 located in the peripheralarea of substrate 808 and connected to one RF output port. All of theminiature discrete, voltage to skin application elements 812 protrudingfrom the substrate surface and terminated by dome type shapes areconnected together to the other port of the RF output transformer. Theparticular tip has 64 elements, although other designs with differentnumber of elements are possible. The further advantage of this solutionis that the resistance variations may be more obvious since there is nocompetition between the electrodes located in the even and unevencontact strips, thus preventing the undesired partial imprint on theskin and the accompanied pain. The area of the voltage to skinapplication elements 804 is substantially larger than the area of theterminated by dome type shapes elements 812. Tip 800 possesses amechanism 820 enabling quick removal and attachment of the tip to theapplicator and RF voltage connection elements (not shown).

The electric scheme and the tip structure disclosed above eliminateelectrical shock feeling, reduce or eliminate the pain associated withthe treatment and increase the treatment efficacy. The isolatingtransformer is located very close to the application tip to reduceground currents through parasitic capacitance. Series capacitors locatedin the path to the electrodes filter out low frequency currents whichare produced by plasma formed at the electrodes and fast current limitersets a maximum to the current which flows into the skin.

Typical operating parameters of the apparatus are:

Voltage on high impedance load: 850Vp-p

Current: 50-400 mA

Pulse length: 10-150 msec

Energy per pulse (Actual energy delivered to the skin): 0.5-4 J, moretypical 1-2 J.

Frequency of the RF: 1 MHz, although 100 kHz up to 10 MHz may beconsidered.

Typical control parameters for the asymmetrical tip, 64 pins, 250microns each:

High resistance limit for cutting of pulses for pain reduction: >1600Ohms (for 64 pins asymmetrical tip)

Low resistance limit for cutting low efficiency pulses: <200 Ohms (for64 pins asymmetrical tip)

Range of resistance where control adds energy to dry the skin: 200-600Ohms (for 64 pins asymmetrical tip)

1-16. (canceled)
 17. An RF skin treatment apparatus, comprising: an RF voltage source configured to apply an RF pulse to skin; and at least one processor configured to: monitor skin impedance as the RF pulse is applied to the skin; and vary the RF pulse in response to the monitored skin impedance in order cause ablation of the skin, wherein the at least one processor is further configured to cut the RF pulse when the monitored skin impedance is beyond a pre-set threshold.
 18. The apparatus of claim 17, wherein the at least one processor is configured to monitor skin impedance in a vicinity of stratum corneum.
 19. The apparatus of claim 17, wherein the threshold is a high pre-set threshold.
 20. The apparatus of claim 17, wherein the pre-set threshold is greater than about 1600 Ohms.
 21. The apparatus of claim 17, wherein the at least one processor is further configured to cut the RF pulse when the monitored skin impedance is below a low pre-set threshold.
 22. The apparatus of claim 21, wherein the low pre-set threshold is less than about 600 Ohms.
 23. The apparatus of claim 17, wherein the at least one processor is configured to add energy when skin resistance corresponds to a dry skin measurement.
 24. The apparatus of claim 23, wherein the dry skin measurement is between about 200 and 600 Ohms.
 25. The apparatus of claim 17, further configured to continuously sense impedance during a pulse.
 26. The apparatus of claim 17, further configured to sense impedance discontinuously during a pulse.
 27. The apparatus of claim 17, wherein the apparatus is configured to either continuously or discontinuously monitor impedance during a pulse by sensing current.
 28. The apparatus of claim 17, further configured to notify an operator of inefficient pulses.
 29. The apparatus of claim 17, further configured to cause fractional treatment of the skin.
 30. The apparatus of claim 17, wherein the at least one processor is part of a controller.
 31. The apparatus of claim 17, further configured for calibration prior to a treatment.
 32. The apparatus of claim 17, further configured for connection to a plurality of voltage to skin electrodes.
 33. The apparatus of claim 17, further configured for connection to a tip having an asymmetrical electrode arrangement.
 34. The apparatus of claim 33, wherein the asymmetrical electrode arrangement includes at least one electrode having a size greater than a size of another electrode.
 35. The apparatus of claim 34, wherein the asymmetrical electrode arrangement includes a plurality of energy applying electrodes including electrodes of a first size, and at least one at least one larger electrode of a second size located at a periphery of the plurality of energy applying electrodes, the second size being substantially greater than the first size.
 36. The apparatus of claim 35, wherein a combined area of the at least one larger electrode is substantially greater than a combined area of the energy applying electrodes.
 37. The apparatus of claim 17, wherein the at least one processor is configured to vary the RF pulse by increasing a time of the RF pulse.
 38. The apparatus of claim 17, wherein the at least one processor is configured to vary the RF pulse in order to deliver a pre-set amount of energy to the skin.
 39. The apparatus of claim 17, wherein the at least one processor is configured to monitor impedance by receiving measurements of current during fractional skin treatment. 